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Regulatory Science

PolyPid secures FDA Priority Review for D-PLEX100 NDA

The Israeli biotech's surgical site infection candidate has a PDUFA date of 28 November 2026, a quarter ahead of prior guidance.
The Israeli biotech's surgical site infection candidate has a PDUFA date of 28 November 2026, a quarter ahead of prior guidance.
The Biotech Times Editorial Team  · 
Biologics

Crystalys raises $130m Series B for gout drug dotinurad

The oversubscribed round will fund two Phase 3 trials and commercialisation preparation for dotinurad, a once-daily URAT1 inhibitor for gout.
The oversubscribed round will fund two Phase 3 trials and commercialisation preparation for dotinurad, a once-daily URAT1 inhibitor for gout.
The Biotech Times Editorial Team  · 

Mission Therapeutics divests AKI asset MTX652 to Dimerix for up to $292m

The Cambridge biotech sheds its renal USP30 programme to fund its Phase 1 Parkinson's candidate MTX325, receiving milestones and tiered royalties.
The Cambridge biotech sheds its renal USP30 programme to fund its Phase 1 Parkinson's candidate MTX325, receiving milestones and tiered royalties.
The Biotech Times Editorial Team  · 
Biologics

Cellution Biologics acquires SimpliDerm ADM business for up to $11m

Cellution Biologics is buying Elutia's SimpliDerm acellular dermal matrix unit to enter the US reconstructive surgery market.
Cellution Biologics is buying Elutia's SimpliDerm acellular dermal matrix unit to enter the US reconstructive surgery market.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

DBV Technologies targets Q3 BLA filing for VIASKIN Peanut Patch

DBV Technologies expects to submit its peanut-patch BLA in Q3 2026, backed by $174.9m in cash and active FDA engagement.
DBV Technologies expects to submit its peanut-patch BLA in Q3 2026, backed by $174.9m in cash and active FDA engagement.
The Biotech Times Editorial Team  · 

AMT Medical SAFE-CAB II trial data published in JTCVS

AMT Medical's sutureless, laser-assisted coronary bypass system met its safety endpoint in 71 patients, with 97.5% patency using the latest catheter.
AMT Medical's sutureless, laser-assisted coronary bypass system met its safety endpoint in 71 patients, with 97.5% patency using the latest catheter.
The Biotech Times Editorial Team  · 
Biologics

Angelini Pharma completes $4.1bn Catalyst Pharmaceuticals buyout

The Italian pharma group has taken full ownership of Nasdaq-listed Catalyst, backed by €1bn each from Blackstone and CDP Equity.
The Italian pharma group has taken full ownership of Nasdaq-listed Catalyst, backed by €1bn each from Blackstone and CDP Equity.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Arbutus files international LNP patent suits against Pfizer and BioNTech

Arbutus and Genevant have launched three international lawsuits over LNP patents while banking $178m from a Moderna settlement.
Arbutus and Genevant have launched three international lawsuits over LNP patents while banking $178m from a Moderna settlement.
The Biotech Times Editorial Team  · 

Intuitive Surgical Q2 revenue rises 19% as da Vinci placements surge

The robotic-surgery giant posted $2.89bn in Q2 revenue and placed 468 da Vinci systems, as global procedure volumes grew 16% year-on-year.
The robotic-surgery giant posted $2.89bn in Q2 revenue and placed 468 da Vinci systems, as global procedure volumes grew 16% year-on-year.
The Biotech Times Editorial Team  · 

IPG Photonics bids €300m for Lumibird Medical to build laser platform

IPG Photonics has made a binding offer to acquire ophthalmic laser maker Lumibird Medical for up to €350m, combining ophthalmology and urology franchises.
IPG Photonics has made a binding offer to acquire ophthalmic laser maker Lumibird Medical for up to €350m, combining ophthalmology and urology franchises.
The Biotech Times Editorial Team  · 

RapidPulse closes $48m Series B to advance TURBO stroke trial

The Miami medtech secured an oversubscribed round co-led by Medtronic to fund its IDE study of pulsed aspiration thrombectomy and pursue FDA clearance.
The Miami medtech secured an oversubscribed round co-led by Medtronic to fund its IDE study of pulsed aspiration thrombectomy and pursue FDA clearance.
The Biotech Times Editorial Team  · 
Digital Health

Kestra Medical secures $200m non-dilutive loan facility with Pharmakon

The Nasdaq-listed wearable cardiovascular device maker replaces a $45m term loan and unlocks up to $357m in total liquidity.
The Nasdaq-listed wearable cardiovascular device maker replaces a $45m term loan and unlocks up to $357m in total liquidity.
The Biotech Times Editorial Team  · 
Biologics

Spero Therapeutics raises $105m royalty financing to fund SP001 Phase 2

The Cambridge biotech is monetising Utebzi royalties via a KKR-backed deal to fund its anti-CD40L immunology candidate SP001.
The Cambridge biotech is monetising Utebzi royalties via a KKR-backed deal to fund its anti-CD40L immunology candidate SP001.
The Biotech Times Editorial Team  · 
Biologics

Aligos receives $25m upfront as China HBV licence deal activates

Aligos Therapeutics has received the first cash payment from its Greater China licence of HBV candidate pevifoscorvir sodium, which also secured China's Breakthrough
Aligos Therapeutics has received the first cash payment from its Greater China licence of HBV candidate pevifoscorvir sodium, which also secured China's Breakthrough
The Biotech Times Editorial Team  · 
Biotech

Taranis Builds Saudi Biotech Ecosystem

Taranis Capital launches a biotech fund and Helix8 incubator to accelerate Saudi Arabia’s life sciences ambitions under Vision 2030.

Foundations Before Breakthroughs: Building Saudi Arabia’s Biotech Future from First Principles

How Taranis Capital’s Biotech Growth Fund and the Helix8 incubator are answering the Kingdom’s earliest-stage challenge

The Biotech Times Editorial Team  · 
Biotech

PetMed Express confirms revised $3 takeover bid from SilverCape

SilverCape Investments has lowered its unsolicited offer to $3.00 per share, down from $4.00 in December, as PetMeds' board evaluates its options.
SilverCape Investments has lowered its unsolicited offer to $3.00 per share, down from $4.00 in December, as PetMeds' board evaluates its options.
The Biotech Times Editorial Team  · 
Genomics

Oryzon Genomics raises €12m and secures €25m COFIDES commitment

The Barcelona epigenetics biotech priced 4.4 million new shares at €2.70 each and secured a €25m anchor commitment from Spain's Social Impact
The Barcelona epigenetics biotech priced 4.4 million new shares at €2.70 each and secured a €25m anchor commitment from Spain's Social Impact
The Biotech Times Editorial Team  · 
Bioinformatics
Biologics

Corten Capital and Ampersand acquire Beacon Intelligence in PE buyout

The deal separates Beacon from the Hanson Wade Group, giving the R&D intelligence platform independent status backed by Corten's €680m second fund.
The deal separates Beacon from the Hanson Wade Group, giving the R&D intelligence platform independent status backed by Corten's €680m second fund.
The Biotech Times Editorial Team  · 
Biologics

Junshi Biosciences licenses IL-17A antibody roconkibart to Fosun Wanbang

Junshi Biosciences will receive RMB215m upfront plus milestones and royalties under a Greater China licensing deal for its anti-IL-17A antibody.
Junshi Biosciences will receive RMB215m upfront plus milestones and royalties under a Greater China licensing deal for its anti-IL-17A antibody.
The Biotech Times Editorial Team  · 
Biologics

Abivax prices upsized $800M ADS offering to fund obefazimod launch

The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod
The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod
The Biotech Times Editorial Team  · 
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